Friday, January 4, 2019

FluMist ® Quadrivalent - The Cautions & Side Effects

If you or your family members get immunized for the flu, you might want to take a quick look at the possible complications  and  the contraindications for FluMist ®  Quadrivalent as listed by the company that makes it. Usually your practitioner does not have time to tell you about these cautions and may not even have time to read the cautions and side effects themseleves, so I am taking some pertinent points from the manufacturers data and sharing it with you. I have organized them below. None of this is my own personal opinion. This is all from the manufacturer and I have provided links to their "Prescribing Information" so  you can fact check yourself if you like or get more details.

Just The Facts

Contains MSG -monosodium glutamate - Here is the inactive ingredient list: monosodium glutamate, gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin. (gentamicin is an antibiotic)

Contains egg residue. If you have an egg allergy, you should not be using it.

Do not give to children and adolsescents up to 17 years of age who are receiving aspirin therapy due to the association of Reye's syndrome with aspirin and wild-type influenza infection.

• There is a risk of hopsitalization and wheezing in children under 2 years of age who receive FluMist ®  Trivalent and they list this as possible with the Quadrivalent also .

• Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. 

• FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing.

• If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks.

• The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years. Among children 2-17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18-49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat

How Does FluMist ®  Quadrivalent  work? Immune mechanisms conferring protection against influenza following receipt of FluMist Quadrivalent vaccine are not fully understood; serum antibodies, mucosal antibodies, and influenza-specific T cell may play a role. 

• FluMist and FluMist Quadrivalent contain live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients (shedding). FluMist Quad FluMist  and trivalent has not been studied in immunocompromised persons. The effectiveness of FluMist has not been studied in immunocompromised persons.

The safety of FluMist Quadrivalent in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established.

Management of Acute Allergic Reactions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine

 FluMist ® Quadrivalent may not protect all individuals receiving the vaccine. I did not see a test of effectiveness for FluMist Quadrivalent but did see this one for FluMist 
The primary endpoint of the trial was the reduction in the proportion of participants with one or more episodes of any febrile illness, and prospective secondary endpoints were severe febrile illness and febrile upper respiratory illness. Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50 through 64 years of age. Primary and secondary effectiveness endpoints from the age group 18 through 49 years are presented in Table 8. Effectiveness was not demonstrated for the primary endpoint in adults 18 through 49 years of age.

One last list of cautions from their paperwork:
Who may not be able to get FluMist Quadrivalent?
Tell your healthcare provider if you or your child: are currently wheezing, have a history of wheezing if under 5 years old, have had Guillain-Barré syndrome, have a weakenedimmune system or live with someone who has a severely weakened immune system, have problems with your heart, kidneys, or lungs, have diabetes, are pregnant or nursing, are taking Tamiflu®, Relenza®, amantadine® or rimantadine®. (Remember that your practitioner may not even know these are issues regarding FluMist®  Quadrivalent and you may need to educate them.)

For more details or to check up on my data, here is the manufacturers disclosure and prescribing information.